Lupin has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Applications (ANDA) for Amifampridine Tablets, 10 mg. Amifampridine Tablets, 10 mg, bioequivalent to the reference listed drug (RLD), Firdapse Tablets, 10 mg, of Catalyst Pharmaceuticals, Inc., for the indication in the approved labeling. The company is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity.
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
